Automatic apparatus for urinary bladder irrigation

ABSTRACT

An apparatus for the automatic irrigation of urinary bladders includes a means to cycle the inflation, deflation and flushing of the bladder. The apparatus includes a supply vessel, two flow control valves, a supply tube with a bladder catheter and timing means to control one of the flow control valves. A pump, controlled by the timing means, may also be used.

United States Patent [1113,570,488 [72 Inventors Mordechai Diskin [56]References Cited Haif UNITED STATES PATENTS 2,629,399 2/1953 Kulick128/227 [21] Appl. No. 823,780

[22] Filed May 12, I969 Continuation-impart of Ser. No. 588,643, Oct, 5,1966, Pat. No. 3,481,334

Mar. 16, 1971 Technion Research & Development Foundation Limited [45]Patented [73] Assignee [54] AUTOMATIC APPARATUS FOR URINARY [50] FieldofSearch 3,185,153 5/1965 Leucci... 128/227 3,329,147 7/1967 Barron128/230 3,410,268 11/1968 Leucci 128/227 Primary Examiner-Richard A.Gaudet Assistant Examiner-Ronald L. Frinks Attorneys-Bierman and Biermanand Jordan B. Bierman vessel, two flow control valves, a supply tubewith a bladder' catheter and timing means to control one of the flowcontrol valves. A pump, controlled by the timing means, may also beused.

PatmteclJMa rch 16, 1971 i 3570,4158

AUTOMATIC APPARATUS FOR URINARY BLADDER IRRIGATION This application is acontinuation-in-part application based upon the applicants priorapplication Ser. No. 588,643 entitied Apparatus for Urinary Bladderirrigation, and filed Oct. 5, l966,now US. Pat. No. 3,48l,334.

This invention relates to an apparatusfor urinary bladder irrigation.

It is the object of the invention to provide an apparatus for theautomatic irrigation of urinary bladders. This irrigation consists ofthe automatic performance of one or more cycles consisting of the stepsof inflation, deflation, and flushing of the urinary bladder with asolution prescribed for this purpose, without requiring attendance of anoperator, except to initially set up and start the apparatus action.

Previous medical practice has been to perform all operations forflushing, inflation and deflation of urinary bladders manually, byadjusting the setting of a restriction valve in a inlet tube conductingthe solution used for flushing into a catheter inserted into thebladder, and by adjusting the setting of another similar valve in adischarge tube connected to the catheter for conducting the solution outof the bladder.

The first type of irrigation cycle in-current practice consists of thefollowing three steps:

1.A A steady flushing of the urinary bladder at a low rate of flow offlushing solution, that does not cause any inflation of the bladder.This part of the irrigation cycle is of a relatively long time duration.

LB The relatively rapid inflation of the urinary bladder by chargingfluid into it at a flow rate considerably greater than the rate in step(LA). The inflation during this part of the cycle is terminated after acertain desired period of time, or when the pressure inthe bladderreaches a predetermined value.

l.C The rapid deflation of the bladder (all references to bladderhenceforth will mean urinary bladder") by permitting it to be emptied ofthe fluid which it contains. During this deflation, inflow to thebladder is resumed at a rate equal to that in step (LA).

This step ends when the bladder is deflated, and the end of this stepcompletes the cycle.

The cycle is with step (LA).

A second type of irrigation cycle in current practice consists of thefollowing two steps: 2.A A steady inflation of the bladder by chargingit with flushing solution at a constant small rate of flow over arelatively long period of time. The inflation terminates after a certaindesired period of time, or when the bladder pressure reaches apredetermined value.

2.8 Rapid deflation of the bladder by permitting the emptying out of thefluid it contains. During deflation, The steady inflow of flushingsolution is maintained at the flow rate of step (2.A). The deflationstep is terminated after a certain desired period of time or when thebladder is deflated. The end of this step completes the cycle.

The cycle is resumed with step (2.A).

The requirements of the first cycle, steps 1. A, B and C, are such thatin previous practice the cycle was not performed automatically, butrequired operation by an operator.

Regarding the operations of the second cyclesteps (2.A) and (2.B)thesewere usually also carried out manually. One technique in previouspractice for accomplishing the cycle automatically was by using a siphontube after the outlet tube of the catheter was inserted into thebladder. The siphon is primed when the pressure in the bladder issufficiently great to force liquid up the leg of the siphon and overinto the drain (or outlet) leg of the siphon. This device, used inprevious practice, is thus responsive to pressure in the bladder toeither permit steady inflation of the bladder (2.A), (2.A) or rapiddeflation (23). According to this previous device, the length of timethe inflation and deflationsteps persist are not independently setvariables. In addition, using this previous technique, the operator mustmake a manual adjustment of the flow rate(s) desired.

In order to perform the above-described cycles, any apparatus used forirrigating bladders should have incorporated into it-at the veryleast-means for varying the flow rate(s) of the flushing solution intothe bladder, and means for varying the duration of time of each step ofthe cycle. Additionally, it should be provided with means for sensingand indicating pressure in the bladder, and means for terminating theinflation steps of the cycle, when bladder pressure reaches apredetermined value. Finally, it is highly desired that theabove-described cycles be performed automatically in order not torequire the attendance of an operator to perform the bladder irrigationcycles. I

The advantages claimed for one or more of the forms of the apparatus ofthis invention, to be described more fully in the following section,are:

1. It provides for the automatic irrigation flushing, inflation anddeflection-of bladders according to a predetermined cycle based upontime and/or bladder pressure.

2. The rate of flushing, the rate of inflation, and the length of thesteps in the cycle(s)"can be set to any predetermined values, within thelimitations set by the apparatus size, depending upon the needs of theindividual patient. Flow rates, and lengths of time for each of thesteps can be changed conveniently during the treatment process if thisis indicated.

3. The apparatus is provided with a means for indicating bladderpressure and includes means for terminating bladder inflation as soon asa predetermined pressure is obtained.

4. The apparatus makes use of a closed system of sterilized piping fromthe supply bottle to the bladder. This greatly reduces the danger ofinfection. The system piping and catheter can be sterilized on theirown. The pump(s) and valve(s) are external to the piping and do notconstitute a source of contamination for the flushing solution.

The invention is illustrated, in several of its modifications, given byway of examplein its application to urinary bladder irrigation, in theaccompanying drawings, in which:

FIG. 1 is a schematic drawing showing the arrangement of the elements ofthe apparatus which utilizes gravity flow of the irrigating fluid, buthaving a choice of two flow rates; and

FIG. 2 is a schematic drawing showing the arrangement of the elements ofthe apparatus which utilize a pump to circulate the irrigating fluid.

The urinary bladder irrigation apparatus illustrated in FIG. 1 comprisesa container 1 for supplying the irrigation fluid 2 to the irrigationsystem, which container has provided to it an air inlet 3 permitting theirrigation fluid to flow under the action of gravity, through the flowrate regulating valve 8, the catheter supply tube 4, the inlet tube ofcatheter 5, the urinary bladder 6, the outlet tube of catheter 5, andthe discharge tube 7. The flow rate is determined by the setting of thevalve 8. The irrigation cycle may be partly controlled by the outletflow control 10, which receives its commands from a timing device 9.

The outlet flow control 10 may be one of a number of broad classes ofdevices used to control flow. For example, it could be constructed of asimple electric solenoid clamp that either firmly grips the dischargetube 7 (which in this case should be of a flexible material such asplastic tubing), thus preventing flow, or, when the solenoid clamp isnot actuated, the tube 7 permits free flow of fluid through itself.-

The outlet flow control device 10 could be a solenoidoperated valvewhich is either opened orclosed to permit or prevent flow. The outletflow control device could also be a hydraulic valve either opened orclosed, obtaining command power electrically, pneumatically, orhydraulically, for'example.

The timing device 9 could be, for example, an electrically driven clockhaving a set of timing cams or contacts to open and close according tothe cycle of irrigation desired. The timing device need not beelectrically operated. It could be based on mechanical, hydraulic,pneumatic or other means of tir'ning, with provision for providing acommand to the outlet flow control device it).

In addition, a second flow rate regulating valve 11 is used in parallelwith the first flow regulating valve 8. This permits the establishmentof two independent rates of flow. For example, in initially adjustingthe apparatus for the desired low flow rate flushing (which does notcause inflation of the bladder), valve 11 is maintained in its closedposition, and outlet control is not energized. The desired low rate offlow is obtained by adjusting the flow regulating valve 8. When timer 9gives the valve 11, which has been previously set to the higher rate offlow, a command to open, and at the same time closes the outlet control10, the inflation part of the irrigation cycle commences.

irrigating fluid 2 from the container 1 will now flow at a relativelyhigh rate, through valve 11, the catheter supply tube 4, the catheter 5,and into the bladder 65. The bladder will then begin to inflate asirrigating fluid is forced into it. After a sufficient period of time,the timer 9 acts to deenergize both valve 11 (which closes), and outletflow control 10 (which opens). The low flow rate flushing mode ofoperation is thus reestablished.

FIG. 2 shows an apparatus for irrigating bladders in which the pressurefor driving the irrigation solution through the system is provided by apump 13 driven by motor 12. In general, the pump may be set to deliver arelatively high flow rate. During flushing the rate pump 13 woulddeliver irrigating solution to the bladder, or simply permit such flowdue to gravity. For this part of the cycle, outlet flow control 10 wouldbe open permitting discharge of fluid out through the discharge tube 7.For rapid inflation of the bladder, the high flow rate of pump 13 isused. The pump 13 is controlled from timing device 9 which, for theinflation part of the cycle also closes outlet flow control 10, thuspermitting the irrigating fluid to be forced into the bladder 6, causingit to inflate, since the fluid is now without any outlet. To return tothe flushing part of the cycle, timer 9 would act to deenergize outletflow control 10, and at the same time would switch out the high flowrate pump 13.

A suitable pump for the application is a positive displacement pump. Onesuch pump, the Sigma" pump (manufactured by the Sigma Pump Co., U.S.A.)is excellently suited to the bladder irrigating devices of thisinvention.

In operation, the pump moves a series of fingers up and down over thesupply tube in what is called peristaltic action. The supply tube 4would have to be made in this case of flexible material (such as plasticor rubber tubing). An important advantage is obtained, since theirrigating solution never comes into contact with matter outside thesterilized supply bottle, tubing 4, catheter 5, discharge tube 7, andthe bladder 6. Thus, all parts of the system other than the bladdercoming into contact with the irrigating solution can be sterilized. Thepump 13 circulates the solution without contacting the solution, and isthus no source of contamination.

A piezometric tube 16 is shown connected to the discharge tube 7. Theheight to which liquid will stand in this tube is directly proportionalto the pressure existing in the bladder. Further, since tube 16 is opento the atmosphere at its upper end, it acts as a safety device. Ifbladder pressure-for any reason whatsoever-is permitted to riseunchecked liquid will overflow the open top without permitting thepressure to rise to dangerous levels. (This is particularly importantwhen the apparatus uses pumps or other mechanical means, capable ofexerting very high pressure, for forcing the irrigating solution throughthe system).

The piezometric tube 16 of FIG. 2 is shown with a liquid level detectiondevice 17 attached, whose purpose is to react to an excessive rise ofsolution level in the tube 16. (This condition occurring when pressurein the bladder is too high.) When excessive pressure occurs, liquidlevel detection device 17 acts to deenergize outlet flow control 10, andthus fluid from bladder 6 will be permitted to flow out rapidly, thusrelieving excessive pressure and preventing further inflation of thebladder. The liquid level detection device could be in the form ofelectrodes that permita current to pass through them when they arecovered y the irrigating solution. Other forms of liquid level detectorsare, for example, a photoelectric relay or float operated switch. Inplace ofthe piezometric tube 16, a Bourdon tube type or other typepressure gauge may also be used to indicate bladder pressure. Equippedwith a set of contacts that operate when a certain pressure is reached,this pressurstat," by opening a set of contacts, deencrgizes the outletflow control 10 when bladder pressure gets too high.

We claim:

1. An apparatus for urinary bladder irrigation comprising incombination: a vessel containing a solution for irrigating the bladder,a first restrictive-type flow control means having its inlet connectedto the outlet of the vessel, a supply tube carrying the irrigatingsolution, whose inlet is connected to the outlet of the flow controlmeans, a catheter having an inlet tube and an outlet connection forrespectively feeding and discharging the irrigating solution to thebladder, said inlet tube being connected to the outlet of the supplytube, a discharge tube whose inlet is connected to the outlet connectionofthe catheter, an outlet flowcontrol means for blocking or permittingflow in the discharge tube, a timing means for operating the outlet flowcontrol means according to a predetermined cycle of operations, a secondrestrictive type flow control means connected in parallel with the saidfirst restrictive flow control means, said second restrictive flowcontrol means is being connected to and operated automatically bycommand from the said timing means, according to a predetermined cycle.

2. An apparatus as described in claim I in which said second restrictiveflow control device is of a two-position type, operated automatically bycommand from the timing means of the apparatus of claim 1, in which thefirst position of said second flow control valve blocks flowtherethrough, and the second position permits a high rate of flow of theirrigating fluid, according to a predetermined cycle of operations.

3. An apparatus as described in claim 1 having, in addition, a powersource, a pump inserted between the catheter inlet tube and the firstrestrictive flow control means, which pump is driven from said powersource energized by the timing means of the apparatus according to apredetermined cycle of operations.

4. An apparatus according to claim 3 which has, in addition, a bladderpressure sensing means which acts to control the outlet flow controlmeans, which pressure sensing means acts to ensure a free flow conditionof the outlet flow control means when a certain predetermined pressureis obtained within the bladder.

1. An apparatus for urinary bladder irrigation comprising incombination: a vessel containing a solution for irrigating the bladder,a first restrictive-type flow control means having its inlet connectedto the outlet of the vessel, a supply tube carrying the irrigatingsolution, whose inlet is connected to the outlet of the flow controlmeans, a catheter having an inlet tube and an outlet connection forrespectively feeding and discharging the irrigating solution to thebladder, said inlet tube being connected to the outlet of the supplytube, a discharge tube whose inlet is connected to the outlet connectionof the catheter, an outlet flow control means for blocking or permittingflow in the discharge tube, a timing means for operating the outlet flowcontrol means according to a predetermined cycle of operations, a secondrestrictive type flow control means connected in parallel with the saidfirst restrictive flow control means, said second restrictive flowcontrol means is being connected to and operated automatically bycommand from the said timing means, according to a predetermined cycle.2. An apparatus as described in claim 1 in which said second restrictiveflow control device is of a two-position type, operated automatically bycommand from the timing means of the apparatus of claim 1, in which thefirst position of said second flow control valve blocks flowtherethrough, and the second position permits a high rate of flow of theirrigating fluid, according to a predetermined cycle of operations. 3.An apparatus as described in claim 1 having, in addition, a powersource, a pump inserted between the catheter inlet tube and the firstrestrictive flow control means, whiCh pump is driven from said powersource energized by the timing means of the apparatus according to apredetermined cycle of operations.
 4. An apparatus according to claim 3which has, in addition, a bladder pressure sensing means which acts tocontrol the outlet flow control means, which pressure sensing means actsto ensure a free flow condition of the outlet flow control means when acertain predetermined pressure is obtained within the bladder.